Import Alert 89-10

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 89-10

Published Date: 03/18/2011

Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Implantable Devices Made from Proplast"

Reason for Alert:

A series of inspections of the Houston based firms beginning in March 1989 through February 1991, disclosed numerous deviations from Good Manufacturing Practices (GMP's) and from the Medical Device Reporting Regulations (MDR's). The inspections also disclosed that TMJ devices (fossa and condyle) were being manufactured without benefit of marketing clearance, i.e., 510(k); and that unapproved Class III hip implants were being exported even though export permission had been withdrawn.

Seizure actions were accomplished which prevented additional distribution of adulterated and misbranded devices. The seizure actions were upheld by court rulings.

Guidance:

Districts may detain, without sampling and analysis, all implants which reference Proplast, Proplast II, or Proplast HA, as indicated under "Product Decription" section of this alert.

When these products are detained, contact DAL-DO, Compliance Branch.

Product Description:

Various implantable devices consisting in whole or in part of Proplast, Proplast II, or Proplast HA including but not limited to:

1. Preformed facial Implants

a. Ocular Globe

b. Zygomatic Implants

c. Malar Implants

d. Mandibular Angle Implants/and Condyle

e. Pre-Maxillary Implants

f. Chin Implants

g. Nasal Implants

h. Otoplasty/Ossicular

2. Blocks for facial and other reconstruction

3. Sheets for facial and other reconstruction

4. Temporomandibular Joint (TMJ) Implants

a. Glenoid Fossa

b. Condyle

c. Interpositional Implants

5. Orthopedic Implants

a. Staple Cushion Pad

b. Anaform Femoral Endoprosthesis

c. Tissue Cushion Pad

d. Trochanter Pad

e. Trapezium Implants

6. Custom Implants, i.e., mandible, forehead, maxilla,

pectus, orbital areas, as well as any other custom

configuration constructed of Proplast, Proplast II, and

Proplast HA.

Charge:

All articles, charge:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device, and that a notice or other information respecting it was not provided as required by Section 510(k), [Misbranding, Section 502(o)]."

OASIS charge code - NO 510(K)

In addition, for the fossas, condyles, and interpositional implants, charge:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device which is misbranded in that it is dangerous to health when used in the dosage or manner; or with the frequency or duration prescribed, recommended, or suggested in the labeling. [Misbranding, Section 502(j)]."

OASIS charge code - DANGEROUS

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device, the label of which fails to bear adequate directions for use [Misbranding, Section 502(f)(1)]."

OASIS charge code - DIRECTIONS

Additionally, for the hip implants, charge:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a Class III device without an approved PMA (Premarket Approval) and is not exempt from such approval (i.e., Investigational Device Exemption,(IDE)), [Adulteration, Section 501(f)(1)(B)]."